NCT05458245

Brief Summary

TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae). Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia. In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021. At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 11, 2022

Last Update Submit

July 15, 2022

Conditions

Keywords

dermacentorDEBONEL

Outcome Measures

Primary Outcomes (1)

  • Number of cases of TIBOLA

    baseline

Secondary Outcomes (6)

  • Epidemiological and demographic characteristics

    baseline

  • Characteristics of tick bites

    baseline

  • Frequency of the various symptoms and clinical signs of the disease

    baseline

  • Biological results

    baseline

  • Treatment

    baseline

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Definite case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) +/- tick bite noted AND microbiological proof (positive PCR or seroconversion for a microorganism responsible for TIBOLA) OR * Probable case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) AND tick bite noted without microbiological proof.

You may qualify if:

  • Person, minor or major,
  • having been diagnosed with TIBOLA
  • between January 1, 2016 and December 31, 2021
  • at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yves Hansmann

Strasbourg, 67000, France

RECRUITING

Elisabeth Baux

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (1)

  • Kotzyba J, Baux E, Hansmann Y, Boyer P, Jaulhac B, Martinot M, Martha B, Kaeuffer C, Bonijoly T, Bani-Sadr F, Legoff A, Hoefler F, Blot M, Bourdellon L, Zilliox L, Boulanger N, Lefevre B. Tick-borne lymphadenopathy in northeastern France: a human and vector clinical-epidemiological study. Parasit Vectors. 2025 Oct 24;18(1):428. doi: 10.1186/s13071-025-07078-2.

MeSH Terms

Conditions

Spotted Fever Group RickettsiosisRickettsia Infections

Condition Hierarchy (Ancestors)

Rickettsiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsTick-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 14, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations